NCT05465616

Brief Summary

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to-participant enrollment. No additional clinical sites will be used for recruitment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
7mo left

Started Aug 2022

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Aug 2022Dec 2026

First Submitted

Initial submission to the registry

July 8, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2026

Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

4.3 years

First QC Date

July 8, 2022

Last Update Submit

January 21, 2025

Conditions

DiabetesPre Diabetes

Keywords

HealthWellnessNutritionVitaminsSupplementsPrebioticsProbioticsFitnessBlood sugar

Outcome Measures

Primary Outcomes (2)

  • HbA1c Levels

    HbA1c changes in individuals in the interventional arm compared to baseline measurement.

    4 months

  • Insulin Resistance

    Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.

    4 months

Secondary Outcomes (8)

  • BMI

    4 months

  • Cholesterol

    4 months

  • Waist to Hip Ratio

    4 months

  • Cardiovascular Risk

    4 months

  • Patient Health Questionnaire 9 (PHQ 9) Score

    4 months

  • +3 more secondary outcomes

Study Arms (2)

Placebo

NO INTERVENTION

Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.

Viome's Precision Nutrition Program (VPNP)

EXPERIMENTAL

Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.

Dietary Supplement: Viome's Precision Nutrition Program (VPNP)

Interventions

Viome's Precision Nutrition Program (VPNP)DIETARY_SUPPLEMENT

Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.

Viome's Precision Nutrition Program (VPNP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated informed consent form and medical release prior to any trial-specific procedures are performed
  • Females and males aged 18 years or older
  • Able to speak and read English
  • HbA1c between 5.7-8.9% (inclusive), tested within the past 30 days
  • Willing and able to visit a Quest Diagnostic Patient Service Center (PSC)
  • Willing and able to follow the trial instructions and Viome's Precision Nutrition Program
  • Willing and able to use a smartphone and Viome app.

You may not qualify if:

  • Antibiotic use within one month of the GI test
  • Gestation within previous 6 month
  • Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)
  • Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)
  • On a specific diet, such as ketogenic, for the purpose of reducing HbA1c and/or weight within the previous month
  • Taking diet pills
  • Allergy to an ingredient in the MH capsule or stick pack
  • Currently on an investigational product
  • Significant surgery or medical procedure planned
  • Diet or lifestyle change during the trial period, besides those appropriate for trial arm Has followed Viome nutritional recommendations (foods and/or supplements)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusGlucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Momchilo Vuyisich

    Viome

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mory Mehrtash

CONTACT

(425) 300-6933studies@viome.com

Momchilo Vuyisich

CONTACT

(425) 300-6933studies@viome.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded for this study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 20, 2022

Study Start

August 22, 2022

Primary Completion (Estimated)

December 13, 2026

Study Completion (Estimated)

December 13, 2026

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations

US(1)